Type 1a Endoleak in hostile neck anatomies: Endoanchor can fix it! D. Böckler University Hospital Heidelberg, Germany

Type 1a Endoleak in hostile neck anatomies: Endoanchor can fix it! D. Böckler University Hospital Heidelberg, Germany

Disclosures Speaker name: Dittmar Böckler I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Research Grant I do not have any potential conflict of interest

Consequences and Implications of Endoelaks

Incidence of Type I a Endoleak is low 3 year data from ENGAGE-Registy At 1 year n= 1079* At 2 Year n= 900* At 3 Year n= 333* Endoleak (Total) 9.8% (106) 10% (90) 10.2% (34) Type I 0.4% (4) 0.9% (8) 1.2% (4) Type II 8.5% (92) 7.7% (69) 8.1% (27) Type III 0.2% (2) 0.7% (6) 0,3 (1) Type I and/or III 0.6% (6) 1.6% (14) 1.5% (5) *n=evaluable diagnostic images

Predictors of Endograft Failure > Migration and Endoleak Type 1a - Angulated > 60 and short neck - Large maximal AAA diameter - Neck thrombus - Complex iliac artery anatomy - Stiffness of the stentgraft - Postprocedural factors (e.g. neck dilatation) ENDURANT Clinical Program Peppelenbosch N, A report from EUROSTAR. J Vasc Surg 2004;39(2):288 97. Resch T, J Vasc Interv Radiol 1999;10(3):257 66. Albertini JN, Vascular 2005;13(6): 321 6.

Recommendation in Guidelines Type I endoleaks should be treated! Level 2 b, Recommendation B

Options for repair of type 1 EL Cuff extension Balloon expandable stents (e.g. Palmaz) EndoAnchor Embolization (e.g. Onyx) Open Conversion Surveillance?

Example EVAR & Endoanchors in conical neck with Type I EL

EndoAnchors to fix Type 1a Endoleaks Aptus Heli-FX EndoAnchor: - Guide - Applier - Cassette with EndoAnchors EndoAnchor Dimensions: 4.5mm length 3.0mm diameter *Based on ANCHOR Registry, STAPLE-1 & STAPLE-2 US IDE Studies & Heli-FX commercial experience

Concept behind EndoAnchors Intended to provide fixation & augment sealing of endovascular grafts to aortic wall Cook Zenith Gore Excluder Medtronic AneuRx Medtronic Endurant Medtronic Talent

Techniques to use for type I EL circumferential focal (EVAR) focal (TEVAR) Image courtesy of Drs. Muhs & Aruny, Yale New Haven Hospital Image courtesy of Dr. Zhou, Stanford University Image courtesy of Dr. Wheatley, Temple University

Results -Literature

ANCHOR Registry Registry Principal Investigators Registry Design Treatment Arms Duration Follow-up Europe: Dr. Jean-Paul de Vries Chief of Vascular Surgery, St. Antonius Hospital US: Dr. William Jordan Chief of Vascular Surgery/Endovascular Therapy, Univ. of Alabama Prospective, observational, international, multicenter, dual-arm Registry Primary Up to 1000 pts, Prophylactic Revision Up to 1000 pts, Therapeutic 5 Years Per Standard of Care at each center & discretion of Investigator

ANCHOR Registry (Jordan et al, JVS 2014) 319 patients in 43 sites in US and Europe 242 implants (75.9%) at initial procedure 77 implants (24.1 %) for revision

ANCHOR Registry (Jordan et al, JVS 2014)

ANCHOR Registry (n=483) Indications for treatment Primary Arm (n=361) Revision Arm (n=123) Treatment of Type 1a Endoleak 126 (35%) Concern for Late Failure 235 (65%) Late Type 1a Endoleak 76 (62%) Migration & Endoleak 47 (38%) Jordan W et al JVS 2014;60:885 De Vries JP et al, JVS 2014;60:1460-7

ANCHOR Registry Results in treating Type Ia Endoleaks Arm Total Patients Success rate (%) Primary (acute type 1) 126 98% Revision (late type 1) 76 90% No EndoAnchor related SAEs and reinterventions Reasons for unsuccessful results: Primary: 1 unresolved type 1a endoleak resolved @1-M F/U Revision: 6 persistent Type 1a endoleak 1 Pt w/persistent Endoleak (Pre-existing Condition), 2 Pts outside Aptus IFU Other Pts. undergoing Corelab review

ANCHOR results vs. Metaanalysis Studies Meta-analysis, Antoniou et al* ANCHOR Registry Medianes Follow-Up 12-Mths. 10.4-Mths. Type 1 Endoleak in Hostile Necks 20/205** (9.8%) 3/213*** (1.4%) * Antoniou GA et al. A meta-analysis of outcomes of endovascular abdominal aortic aneurysm repair in patients with hostile and friendly neck anatomy. J Vasc Surg 2012 ** Hostile neck criteria: neck length <15 mm and neck angulation > 60 degrees *** Hostile as determined by physician in Primary Arm 20

Comparing EndoAnchor versus Palmaz Rate of persisting Type 1a Endoleak at the end of primary EVAR Studies Persisting Type 1a Endoleak Byrne J et al.* (Palmaz) 8.6% ** ANCHOR Registry 2.2% *Byrne J et al. Does Palmaz XL Stent Deployment for Type 1 Endoleak during Elective or Emergency Endovascular Aneurysm Repair Predict Poor Outcome? A Multivariate Analysis of 1470 Patients. Ann Vasc Surg. 2013 May;27(4):401-11 **Rate includes both emergent and elective patients receiving Palmaz stents during primary EVAR procedure.

Limitations of Endo Anchors Severe neck calcification Thrombusline > 2 mm and > 180º of circumference Distance between stentgraft and aortic wall > 2mm Avci M et al. J Cardiovasc Surg 2012; 53:419-26

Heidelberg Algorythm for Type 1a EL Proximal Type I EL PTA & persisting EL sufficient remaining neck insufficient remaining neck Cuff / fenestrated SG- extension Embolisation or Conservative EndoAnchor Palmaz Stent - kinked neck - non-calcified native aorta - straigt neck - thrombus

Consider primary CHEVAR or FEVAR

Summary Type 1 a Endoleak rate is low within ENGAGE Need for treatment to prevent secondary rupture Several options to treat Type 1 a Endoleak No comparative studies for different modalities Endoanchors are approved for Type I EL and do better than Palmaz stents Anchor registry shows excellent results Consider primary FEVAR/Chimney for unfavorable neck morphology

Type 1a Endoleak in hostile neck anatomies: Endoanchor can fix it! D. Böckler University Hospital Heidelberg, Germany